NCT00514566

Brief Summary

Within the last decade the customary trend of using non absorbable sutures has changed, with numerous studies and meta-analyses advocating the use of slowly absorbable sutures, claiming comparable wound strength with significantly lower incidence of wound complications. It was the objective of this randomized clinical trial to compare two universally accepted suture materials, the non-absorbable Nylon and the slowly absorbable Polydioxanone for midline abdominal closure in the Indian context.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2004

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 10, 2007

Completed
Last Updated

August 10, 2007

Status Verified

August 1, 2007

First QC Date

August 8, 2007

Last Update Submit

August 8, 2007

Conditions

Laparotomy

Keywords

PolyamidePolydioxanoneMidlineAbdominalClosure

Outcome Measures

Primary Outcomes (1)

  • Wound Complications associated with suture material used for closure- Wound Dehiscence, Wound Infection, Incisional Hernia, Suture Sinus, Scar Pain

    2 years

Secondary Outcomes (1)

  • Factors independent of suture materials responsible for wound complications such as age, gender, type of surgery, degree of contamination, surgeon, and presence of a stoma

    2 years

Study Arms (1)

1

ACTIVE COMPARATOR

Surgical Patient undergoing midline laparotomy closure

Device: Suture for midline abdominal closure

Interventions

Suture for midline abdominal closureDEVICE

closure with Polyamide or Polydioxanone

Also known as: Ethicon Inc., Loop no. 1, 150 cm suture length
1

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All patients above 12 years of age undergoing midline abdominal fascial closure using a continuous technique in the Department of Surgery, Christian Medical College and Hospital

You may not qualify if:

  • All patients under 12 years of age
  • Gynaecological operations
  • Abdominal wall hernia repair

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Christian Medical College and Hospital

Ludhiana, Punjab, 141008, India

Location

MeSH Terms

Interventions

Sutures

Intervention Hierarchy (Ancestors)

Surgical Fixation DevicesSurgical EquipmentEquipment and Supplies

Study Officials

  • Rajeev Kapoor, MS(Gen Surg)

    Christian Medical College and Hospital, Ludhiana, India

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 8, 2007

First Posted

August 10, 2007

Study Start

October 1, 2004

Study Completion

April 1, 2006

Last Updated

August 10, 2007

Record last verified: 2007-08

Locations

IN(1)